NA · Exenatide

NCT02962492 trial results

An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes

Change in Beta-hydroxybutyrate Levels in Blood (mM), 12 weeks. Placebo Arm:: -0.23; Dapagliflozin Arm:: 0.63; Exenatide Extended Release Arm:: 0.24; Exenatide Extended Release & Dapagliflozin Arm:: 0.31.

Participants
70
Status
completed
Completed
2021-10-24
Sponsor
University at Buffalo

As posted on ClinicalTrials.gov (NCT02962492), updated at source Feb 29, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02962492 measured first

Change in Beta-hydroxybutyrate Levels in BloodmM · 12 weeks · mean
Placebo Arm:n=11Dapagliflozin Arm:n=15Exenatide Extended Release Arm:n=15Exenatide Extended Release & Dapagliflozin Arm:n=21
-0.23(0.17)0.63(0.22)0.24(0.21)0.31(0.19)
Secondary outcomes

What else it measured

Change in HbA1c Following TreatmentPercent of Hemoglobin (%) · 12 weeks · mean
Dapagliflozin Arm:n=15Exenatide Extended Release Arm:n=15Placebo Arm:n=11Exenatide Extended Release & Dapagliflozin Arm:n=21
-0.3(0.1)-0.4(0.2)-0.1(0.1)-0.9(0.1)
Change in Urinary Beta-hydroxybutyrate (BHB) After 12 Weeks of TreatmentmM · 12 weeks · mean
Placebo Arm:n=11Dapagliflozin Arm:n=15Exenatide Extended Release Arm:n=15Exenatide Extended Release & Dapagliflozin Arm:n=21
1.2(0.5)0.4(0.2)-0.7(0.6)1.1(0.4)
Change in Plasma Glucagonpg/ml · 12 weeks · mean
Placebo Arm:n=11Dapagliflozin Arm:n=15Exenatide Extended Release Arm:n=15Exenatide Extended Release & Dapagliflozin Arm:n=21
2(2)16(10)-15(8)-10(6)
Change in Total Insulin DoseUnits/Kg · 12 weeks · mean
Placebo Arm:n=11Dapagliflozin Arm:n=15Exenatide Extended Release Arm:n=15Exenatide Extended Release & Dapagliflozin Arm:n=21
-0.01(0.02)-0.02(0.02)-0.05(0.02)-0.04(0.02)
The trial

How NCT02962492 was run

The study investigations include evaluation of the acute effects of a single dose of dapagliflozin (10mg), exenatide (5µg), a combination of exenatide and dapagliflozin or placebo under insulinopenic condition and the long term effect under basal conditions before and after 12 weeks treatment with dapagliflozin, Exenatide extended release, a combination of Exenatide extended release and dapagliflozin or placebo on ketogenesis, glucagon and lipolysis.

  • Dapagliflozin Arm:: dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
  • Exenatide extended release Arm:: subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
  • Placebo Arm:: dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
  • Exenatide extended release & dapagliflozin Arm:: Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg
Who could join the trial

Inclusion Criteria: * Type 1 Diabetes for at least 1 year on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) * HbA1c of 7-10% (inclusive) * Ages 18-65 years (inclusive of ages 18 and 65) * BMI 20-30 kg/m2 Exclusion Criteria: * Inability to give informed consent * Inability or refusal to comply with protocol * Use of GLP-1 Receptor Agonists in the last 3 months or DPP-IV and SGLT-2 inhibitors therapy in the last 1 month. * Risk for pancreatitis (e.g., history of gallstones, alcohol abuse, and hypertriglyceridemia) * History of pancreatitis and or chronic pancreatitis * Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) or stroke in the previous 3 months. * Congestive Heart Failure class III or IV or tachyarrhythmia. * Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver function defined as: 1. Aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN 2. Total bilirubin \>2.0 mg/dL (34.2 µmol/L) 3. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody 4. Liver function tests more than 3 times the upper limit of normal * Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women, or eGFR \<60 mL/min/1.73 m2) or history of unstable or rapidly progressing renal disease or end stage renal disease. * History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit. * HIV positive * History of gastroparesis * History of medullary thyroid carcinoma or MEN 2 syndrome * History of recurring UTI * Uncontrolled thyroid disease (documented normal TSH), Cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia. * Prior history of a malignant disease requiring chemotherapy or patients with a prior history of bladder cancer regardless of treatment * Alcoholism or drug addiction. * Hypertriglyceridemia (\>400 mg/dl). * Any other life-threatening, non-cardiac disease * Uncontrolled hypertension (BP \> 160/95 mm of Hg) * Patients with hypotension or at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics or recently donated \>500ml of blood should have careful monitoring of their volume status * Pregnant or breastfeeding patients or patient not willing to use two barrier method contraception during study period (unless sterilized or have an IUD) * Use of hormonal medications, anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, GnRH agonists, glucocorticoids, anabolic steroids, C-19 progestins) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase...

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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